Ex Parte Jiang et al

Board of Patent Appeals and Interferences

Aug 31, 2006

10337417 (B.P.A.I. Aug. 31, 2006)

The opinion in support of the decision being entered today was not w
for publication and is
ritten
not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte YANDONG JIANG and MASSIMO FERRIGNO
____________

Appeal No. 2006-1728
Application No. 10/337,417
Technology Center 3743
____________

ON BRIEF
____________

Before OWENS, LEVY, and NAPPI, Administrative Patent Judges.
LEVY, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal from the examiner's final
rejection of claims 1-13, which are all of the claims pending in
this application.

We REVERSE.

BACKGROUND
The appellants’ invention relates to a method for altering
the body temperature of a patient using a nebulized mist
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Application No. 10/337,417

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(specification, page 1). In particular, the mists include
distinct liquid particles with a small diameter, typically 1-5
microns (specification, page 2). Claim 1 is representative of
the invention, and is reproduced as follows:
1. A method of reducing the body temperature of a patient
for any clinical condition in which a reduction in body
temperature is desirable, comprising:

(a) administering a mist to said patient by ventilation,
wherein:

(i) said mist is generated by a nebulizer and
contains liquid particles having an average
size of no more than 5 microns in diameter;

(ii) said mist comprises a mixture of a
physiologically acceptable gas and a
physiologically acceptable liquid;

(iii) said mist is administered at a temperature
below the body temperature of said patient;

and

(b) maintaining the administration of said mist until said
patient’s body temperature is reduced.

The prior art references of record relied upon by the
examiner in rejecting the appealed claims are:
Michaels et al. (Michaels ‘854) 3,812,854 May 28, 1974
Michaels et al. (Michaels ‘002) 4,595,002 Jun. 17, 1986
Schutt 5,540,225 Jul. 30, 1996
Faithfull et al. (Faithfull) 6,041,777 Mar. 28, 2000
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Claims 1-13 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Schutt in view of Faithful, Michaels
(‘854) and Michaels (‘002).
Rather than reiterate the conflicting viewpoints advanced by
the examiner and the appellants regarding the above-noted
rejections, we make reference to the answer (supplemental answer
mailed December 20, 2005) for the examiner's complete reasoning
in support of the rejection, and to the brief (filed October 21,
2005) and reply brief (also filed October 21, 2005) for the
appellants’ arguments thereagainst.
Only those arguments actually made by appellants have been
considered in this decision. Arguments which appellants could
have made but chose not to make in the brief have not been
considered. See 37 CFR § 41.37(c)(1)(vii)(eff. Sept. 13, 2004).

OPINION
In reaching our decision in this appeal, we have carefully
considered the subject matter on appeal, the rejection advanced
by the examiner, and the evidence of obviousness relied upon by
the examiner as support for the rejection. We have, likewise,
reviewed and taken into consideration, in reaching our decision,
appellants' arguments set forth in the briefs along with the
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examiner's rationale in support of the rejection and arguments in
rebuttal set forth in the examiner's answer.
Upon consideration of the record before us, we make the
determinations which follow. In rejecting claims under 35 U.S.C. § 103, it is
incumbent upon the examiner to establish a factual basis to support the legal conclusion
of obviousness. See In re Fine, 837 F.2d 1071, 1073, 5 USPQ2d 1596, 1598 (Fed. Cir.
1988). In so doing, the examiner is expected to make the factual determinations set
forth in Graham v. John Deere Co., 383 U.S. 1, 17, 148 USPQ 459, 467 (1966). The
examiner must articulate reasons for the examiner's decision. In re Lee, 277 F.3d 1338,
1342, 61 USPQ2d 1430, 1434 (Fed. Cir. 2002). In particular, the examiner must show
that there is a teaching, motivation, or suggestion of a motivation to combine references
relied on as evidence of obviousness. Id. at 1343. “The Board cannot simply reach
conclusions based on the examiner's own understanding or experience - or on his or
her assessment of what would be basic knowledge or common sense. Rather, the
Board must point to some concrete evidence in the record in support of these findings."
In re Zurko, 258 F.3d 1379, 1386, 59 USPQ2d 1693, 1697 (Fed. Cir. 2001). Thus the
examiner must not only assure that the requisite findings are made, based on evidence
of record, but must also explain the reasoning by which the findings are deemed to
support the examiner's conclusion. However, a suggestion, teaching, or motivation to
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combine the relevant prior art teachings does not have to be found explicitly in the prior
art, as the teaching, motivation, or suggestion may be implicit from the prior art as a
whole, rather than expressly stated in the references. The test for an implicit showing is
what the combined teachings, knowledge of one of ordinary skill in the art, and the
nature of the problem to be solved as a whole would have suggested to those of
ordinary skill in the art. In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed.
Cir. 2006) citing In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313 (Fed. Cir. 2000).
See also In re Thrift, 298 F. 3d 1357, 1363, 63 USPQ2d 2002, 2008 (Fed. Cir. 2002).
These showings by the examiner are an essential part of complying with the burden of
presenting a prima facie case of obviousness. Note In re Oetiker, 977 F.2d 1443, 1445,
24 USPQ2d 1443, 1444 (Fed. Cir. 1992). If that burden is met, the burden then shifts to
the applicant to overcome the prima facie case with argument and/or evidence.
Obviousness is then determined on the basis of the evidence as a whole and the
relative persuasiveness of the arguments. See Id.; In re Hedges, 783 F.2d 1038, 1039,
228 USPQ 685, 686 (Fed. Cir. 1986); In re Piasecki, 745 F.2d 1468, 1472, 223 USPQ
785, 788 (Fed. Cir. 1984); and In re Rinehart, 531 F.2d 1048, 1052, 189 USPQ 143,
147 (CCPA 1976).
The examiner's position (answer, page 4) is that Schutt does
not disclose that a nebulizer administers the fluorocarbon. To
overcome this deficiency of Schutt, the examiner turns to
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Faithfull for a teaching of an apparatus for administering
fluorocarbon to the lungs of a patient during partial liquid
ventilation. Faithfull specifies that the fluorocarbon is
administered by a nebulizer (98) in the form of a mist, to be
readily absorbed in the alveolar lung tissue. The examiner
asserts (answer, page 4) that “[i]t appears that the average size
of the nebulized liquid particles must be less than 5 microns,”
and that “it appears that the mist comprises less than 20% liquid
by volume”. The examiner additionally takes the position
(answer, pages 5 and 6) that the disclosure of Schutt (col. 10,
lines 24-25) “fluorocarbon could also be provided as a liquid or
aerosol in combination with an expectorant” makes a clear
suggestion that the procedure could be performed with a mist.
The examiner additionally relies upon the Michaels (‘854) patent
as evidence that nebulizers are capable of producing particles
having a size of less than 5 microns, or less than 2 microns so
that the particles can deposit in the alveoli of the lungs. The
examiner relies upon the Michaels (‘002) patent as evidence that
nebulizers are well known for producing mists that have at least
80% gas by volume.
Appellants' position (brief, page 4) is that the cited
references, even if combined, do not suggest using partial liquid
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ventilation to alter body temperature in a procedure which either
uses mists that are heated and cooled prior to administration or
uses mists in which the average droplet size is maintained at 5
microns or less. It is argued (brief, page 6) that in Schutt, it
is the liquid that is pumped into a patient’s lungs that is used
to effect a temperature change, not a mist.
Appellants additionally argue (id.) that there would be no
motivation to use a mist that is heated or cooled because heat
exchange is already being accomplished by heating or cooling the
perfluorocarbon liquid. As to the assertion of the examiner that
Schutt suggests administering the fluorocarbons as an aerosol,
appellants assert that the examiner has taken the statements in
this passage out of context, because the reference is discussing
the use of fluorocarbons, not in a partial liquid ventilation,
but as a vehicle for administering an expectorant for the purpose
of removing unwanted bronchopulmonary secretions.
It is additionally argued (brief, page 8) that Faithfull
never suggests using partial liquid ventilation as a means for
changing the temperature of a patient’s body, and thus, never
suggests heating or cooling mists prior to when they are
administered to a patient. Appellants further assert (id.) that
Faithfull also fails to teach mists having an average droplet
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diameter of 5 microns or less because there is no motivation to
maintain a small particle size since the lungs are saturated with
a liquid that is exceptionally capable of exchanging oxygen.

From our review of Schutt we find that the disclosure (col.
10, lines 20-28) that
If the lungs have been compromised by an irritant, then
surfactant replacement may be necessary. Oxygenatable
fluorocarbons with positive spreading coefficients and
low vapor pressures could provide an improved lavage
fluid. That fluorocarbon could also be provided as a
liquid or aerosol in combination with an expectorant.
The biocompatible fluorocarbon is easily taken into the
lung and the expectorant additive facilitates the
removal of the secretions of the bronchopulmonary
mucous membrane.

From this disclosure, we find that to remove secretions of the
mucous membranes in the lungs, the fluorocarbon can be provided
as a liquid or aerosol in combination with an expectorant. We
find nothing in this passage, or anywhere else in Schutt, that
would have suggested replacement of the liquid fluorocarbon in
the disclosed invention of Schutt with an aerosol, other than
when used in combination with an expectorant to remove secretions
from a patient’s lungs. That is, we find that the reference to
using an aerosol in combination with an expectorant is for the
purpose of removing lung secretions and not to replace the liquid
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fluorocarbon lung therapy described in Schutt’s specification and
drawings with an aerosol.
Turning to Faithfull, the reference does describe lung
therapy in the form of an apparatus for administering
fluorocarbon to the lungs of a patient during partial liquid
ventilation, where the fluorocarbon is administered from a
nebulizer in the form of a mist. However, there is no prior art
cited by the examiner that shows or suggests heating or cooling a
mist before administering it to a patient, to raise or lower the
patient’s temperature. Schutt does describe heating and cooling
a liquid fluorocarbon before administering it to a patient, but
does not suggest heating and cooling a mist before administering
the mist to the patient to raise or lower body temperature.
Accordingly, even if we combined the teachings of Schutt and
Faithfull, the result would still fall short of independent
claims 1 and 8 because there is no teaching or suggestion in the
prior art for heating or cooling a mist before administering the
mist to a patient to raise or lower the patient’s body
temperature. Although the Michaels patents provide evidence of
the claimed the mist particle size and volume percentage of gas,
these references fail to make up for the basic deficiencies of
the combination of Schutt and Faithfull.
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From all of the above, we find that the examiner has failed
to establish a prima facie case of obviousness of independent
claims 1 and 8. Accordingly, we cannot sustain the rejection of
these claims, or of claims 2-7 and 9-13, which depend therefrom.

CONCLUSION
To summarize, the decision of the examiner to reject claims
1-13 under 35 U.S.C. § 103 is reversed.
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REVERSED

TERRY J. OWENS )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
STUART S. LEVY ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
ROBERT E. NAPPI )
Administrative Patent Judge )
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Application No. 10/337,417

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FITCH, EVEN, TABIN & FLANNERY ATTORNEYS
AND COUNSELLORS AT LAW SUITE 401L
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